# K991962: Eis Dynamic Memory Staples System

- Pathway: 510(k) (Traditional)
- Applicant: Groupe Lepine
- Decided: Jan 10, 2000 after 214 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
118 later devices descend from it; 1 cites it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K011716: The Uni-Clip Staple (2001), 117 descendants of its own
- K061594: Large Uni-Clip Staple (2006), 103 descendants of its own
- K070447: Newdeal Compression Plate (2007), 102 descendants of its own
- K093914: Newdeal Compression Plates (2011), 98 descendants of its own
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own

## Indications for use
The Groupe Lepine EIS dynamic memory staples system was designed and is intended to be used for the fixation of fractures by compressing two bones together after a osteotomy. The staples are intended for bone fixation after corrective osteotomy of the big toe, interphangeal fusion, fractures of the scaphoid or small trauma injuries. The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies or trauma fracture.

Source page: https://510kreport.com/device/K991962
Methodology: https://510kreport.com/methodology